Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-18 @ 12:01 AM
Study NCT ID:
NCT03866603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-20
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rostock International Parkinson's Disease Study (ROPAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the prevalence of genetic etiologies of PD', 'timeFrame': '79 months'}], 'secondaryOutcomes': [{'measure': 'To identify LRRK2-positive PD participants from the primary strata, Establishment of a biomarker in the LRRK2-positive cohort', 'timeFrame': '79 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson´s disease', 'Biomarker', 'LRRK2', 'GBA', 'PD Genetics'], 'conditions': ['Parkinson´s Disease']}, 'referencesModule': {'references': [{'pmid': '22166466', 'type': 'BACKGROUND', 'citation': "Baumann CR. Epidemiology, diagnosis and differential diagnosis in Parkinson's disease tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S90-2. doi: 10.1016/S1353-8020(11)70029-3."}, {'pmid': '39957202', 'type': 'DERIVED', 'citation': "Dayan R, Bick AS, Weill C, Bauer M, Erdman HB, Israel Z, Bergman H, Levin N, Arkadir D. Atrophy-related corticospinal changes in advanced Parkinson's disease are associated with the genetic etiology of the disease. J Parkinsons Dis. 2024 Nov;14(8):1584-1593. doi: 10.3233/JPD-240267. Epub 2024 Nov 4."}]}, 'descriptionModule': {'briefSummary': "Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.", 'detailedDescription': "Parkinson's disease (PD) is one of the most common neurodegenerative disorders worldwide, affecting approximately 1% of individuals older than 60 years and causes progressive disability.\n\nClinical signs and symptoms of PD include the following: asymmetric tremor at rest, bradykinesia, muscle rigidity, postural instability, gait abnormalities including festination and freezing. Onset is typically after the age of 50 years and the disease is commonly slowly progressive. The most common initial finding of PD is a resting tremor in the upper extremity. Over time, participants experience progressive bradykinesia, rigidity, and gait difficulty, while the axial posture becomes progressively flexed. Non-motor symptoms are common in all stages of Parkinson disease and they include constipation, seborrhea, hyposmia or anosmia, sympathetic denervation of the heart, depression and/or apathy, sleep disturbances, cognitive decline and dementia. They may appear prior to the movement disorder and can be used as preclinical markers of PD.\n\nPD is mostly considered as idiopathic disease; however more and more data suggest that it is a disease that involves interaction of genetic and environmental factors. The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD.\n\nThe most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD. First identified in 2004, LRRK2 mutations are currently still the most commonly known cause of PD and account for up to \\~40% of all Parkinson's disease cases in select populations. The majority of reported LRRK2-positive PD patients are Caucasian (63%), whereas all other ethnicities comprise \\~10% or fewer patients of described mutation carriers despite clusters in the Ashkenazi Jewish and Arab Berber populations. With respect to country of origin, the majority of patients were re-ported to reside in Italy or Spain (14% each), Great Britain (10%) or Norway (9%). Definitely pathogenic variants identified in LRRK2 include p.G2019S, p.R1441C/G/H, p.N1437H, p.Y1699C, and, p.I2020T. Of these, the p.R1441G mutation is particularly frequent, as it represents a founder mutation in the Basque population where it is responsible for 46% of all familial PD. Very rarely, this mutation has also been observed in other populations where it arose on a different haplotype. LRRK2 p.Gly2019Ser mutation accounts for about 0.5% simplex cases and \\>5% familial cases in various ethnic groups worldwide. Furthermore, genome-wide association studies have identified common polymorphisms in LRRK2 that associate with idiopathic PD, implicating LRRK2 function in susceptibility to late-onset PD in individuals without pathogenic mutations.\n\nLRRK2 mutations cause PD with age-related penetrance and clinical features identical to late-onset sporadic PD. Biochemical studies support an increase in LRRK2 kinase activity and a decrease in GTPase activity for kinase domain and Roc-COR mutations, respectively. Strong evidence exists that LRRK2 toxicity is kinase dependent, leading to extensive efforts to identify selective and brain-permeable LRRK2 kinase inhibitors for clinical development. LRRK2 kinase inhibition is currently one of the most prevailing disease-modifying therapeutic strategies for PD. Thus, LRRK2 kinase inhibitors are in development as potential Parkinson's disease therapeutics.\n\nFurthermore, there is now evidence showing that LRRK2 expression and phosphorylation levels have a potential as markers of Parkinson's disease. Recently, the presence of Lrrk2 was confirmed in exosomes from human biofluids, including urine and cerebrospinal fluid. Moreover, elevated LRRK2 autophosphorylation was identified in brain-derived and peripheral exosomes in LRRK2-mutation carriers. In summary, it has been shown that markers of LRRK2 activity and function may be detected in human blood and that they are relevant for pathogenesis if PD.\n\nThus, the biochemical analyses of human blood from LRRK2 positive participants and LRRK2 negative participants create a strong base for the development of PD-related biomarkers. This biomarker may in turn be even more accessible than genetic testing and it may serve for diagnosis, prognosis, and prediction of PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants clinically diagnosed with Parkinson's Disease (PD)", 'healthyVolunteers': False, 'eligibilityCriteria': "* Informed consent is obtained from the participant\n* The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years)\n* The participant is between 30 and 80 years old"}, 'identificationModule': {'nctId': 'NCT03866603', 'acronym': 'ROPAD', 'briefTitle': "Rostock International Parkinson's Disease Study (ROPAD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'CENTOGENE GmbH Rostock'}, 'officialTitle': "Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study", 'orgStudyIdInfo': {'id': 'ROPAD 01-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parkinson´s disease individuals', 'description': "* The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years)\n* The participant is between 30 and 80 years old"}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Neuroscience Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California (UC) San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33486', 'city': 'Baco Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorder Center of Baco Raton"}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Linfritz Research Institute', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '34475', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Vero Beach Neurology & Research Institute', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University, Department of Neurology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute for Neurological Disorders', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'WR-CRCN', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Neuroscience Research Institute of NJ', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurologic Institue', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '11772', 'city': 'Brookhaven', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University School of 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de Neurocirurgia E Neurofisiologia Ltda', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '69065-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Israelita de Ensino e Pesquisa Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital, University Health Network, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinik für Neurologie', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '14547', 'city': 'Beelitz', 'country': 'Germany', 'facility': 'Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson', 'geoPoint': {'lat': 52.23812, 'lon': 12.9714}}, {'zip': 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Allianz Marburg (PANAMA)', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'country': 'Germany', 'facility': 'Diakonie-Klinikum Schwäbisch Hall gGmbH', 'geoPoint': {'lat': 49.11127, 'lon': 9.73908}}, {'zip': '07646', 'city': 'Stadtroda', 'country': 'Germany', 'facility': 'Asklepios Fachklinikum Stadtroda Klinik für Neurologie, Schmerztherapie und Schlafmedizin', 'geoPoint': {'lat': 50.85684, 'lon': 11.72677}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '16675', 'city': 'Athens', 'country': 'Greece', 'facility': 'Mediterraneo Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '7747629', 'city': 'Ashdod', 'country': 'Israel', 'facility': 'Samson Assuta Ashdod University Hospital', 'geoPoint': {'lat': 31.79213, 'lon': 34.64966}}, {'zip': '7830604', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai 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